CTD Module 3 Workshop

Join our next hands-on workshop to write your own
​Module 3 of the CTD.

Module 3 describes the Quality aspects of the pharmaceutical product and is a cardinal component of any IND or IMPD submission, required to initiate clinical trials.

It is useful since Day 1 of the project, as a roadmap for development, and it evolves alongside with the CMC Development project, until it reaches the complete, final form, in the NDA, BLA or MAA submission (for marketing approval).

Having a Module 3 at hand, even as a live draft- is extremely useful, and will save you a lot of time and money when needed for submission.

Don't wait for funding.

Don't wait for consultants.

Start writing your Module 3 today and reap the benefits of a smarter CMC Development project and strong knowledge management.

Designated tracks according to the development stage.

Intended for Development teams in startups, and for junior staff in Regulatory Affairs, without prior experience in writing Module 3.

This is a boutique workshop, accepting 3-4 participants in a cohort.

For more details, and to check your eligibility- please register your interest in the box to the right.

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